Comparison of Plasma Neutrophil Gelatinase-Associated Lipocalin (pNGAL) Level in De-resuscitation With Furosemide Group and Control Group

Acute Kidney Injury Due to Sepsis Clinical Trial

Official title:

Comparison of Plasma Neutrophil Gelatinase-Associated Lipocalin (pNGAL) Level in De-Resuscitation With Furosemide Group and Control Group as a Predictor of Sepsis in Acute Kidney Injury Patients in the ICU Within 48 Hours of Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05939245
• Other study ID #: IndonesiaUAnes042
• Status: Recruiting
• Phase: N/A
• Start date: July 24, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: July 2023
• Source: Indonesia University
• Contact: Dita Aditianingsih, M.D, Ph.D
• Phone: +618151819244
• Email: ditaaditiaa[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The impact of early de-resuscitation with furosemide on patients with sepsis-related acute kidney injury using pNGAL as the parameter of acute kidney injury.

Description:

Sepsis-related acute kidney injury (SAKI) is a complication leading to morbidity and mortality in septic patients. Some 50% of AKI patients in the Intensive Care Unit (ICU) are sepsis patients, which is the highest cause of death in the ICU. In sepsis, there is systemic inflammation that causes endothelial damage, which manifests in capillary leakage. Fluid accumulation that has occurred since the patient came to the hospital due to a capillary leak in sepsis and is exacerbated by fluid resuscitation has a negative impact on the kidneys. Therefore, the aim of this study was to assess the effectiveness of early de-resuscitation using furosemide on the incidence of AKI in septic patients using pNGAL as a parameter of AKI.

This study used a double-blind, randomized clinical trial design. This study was conducted on septic patients with a cumulative balance of >1500 mL/day and urine output of 0.8 cc/kg/hour in the ICU of Dr. Cipto Mangunkusumo National Central Public Hospital in the July-December 2023 period. pNGAL levels were checked at the 0th and 48th hours of ICU care. A total of 48 subjects were divided into 2 groups: 24 patients in the treatment group were given a continuous injection of furosemide at 2 mg/hour, and 24 patients in the control group were given a placebo injection at 2 mg/hour. The patient's condition will be followed after the ICU stay for up to 28 days to record the need for renal replacement therapy and death.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Sepsis patients with a cumulative balance of >1500 mL/day and urine output <0.8 cc/kg/hour.

Exclusion Criteria:

• Has undergone a kidney transplant procedure.

• End-stage chronic kidney failure.

• History of heart valve abnormalities.

• Congenital heart disease.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Kidney Injury Due to Sepsis
• Sepsis

Intervention

Procedure:
• Furosemide Injection
Continuous infusion of furosemide is administered starting at 2 mg/hour and can be titrated until the target urine output of 1-2 cc/kg/hour is achieved for 48 hours. In case of hypotension (MAP <65 mmHg), norepinephrine is administered with titration starting at a dose of 0.05 mcg/kg/minute, along with a fluid loading of 4 cc/kg body weight or 300 cc within 5-10 minutes, until the target MAP of =65 mmHg is reached for 48 hours.
• Placebo Injection
Continuous infusion of placebo fluid is administered at a rate of 2 mL/hour. In case of hypotension (MAP <65 mmHg), norepinephrine is administered with titration starting at a dose of 0.05 mcg/kg/minute, along with a fluid loading of 4 cc/kg body weight or 300 cc within 5-10 minutes, until the target MAP of =65 mmHg is reached for 48 hours.

Locations

Country	Name	City	State
Indonesia	Rumah Sakit Cipto Mangunkusumo	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pNGAL concentration	pNGAL measurement using ELISA at baseline (before intervention) and 48 hr after intervention	2 days
Secondary	Mechanical Ventilation Duration	Measuring hours usage of mechanical ventilation	from the first day mechanical ventilation usage until weaned to T-piece, assessed up to 28 days
Secondary	Length of stay in ICU	length of stay in days during and after deresuscitation until the patient meets the ICU discharge criteria	28 days
Secondary	Renal Replacement Therapy	Necessity of renal replacement therapy within 28 days in ICU: needed/ not	28 days
Secondary	Fluid Balance (Daily)	Data extracted from medical record	28 days
Secondary	Lactate Concentration	Lactate measurement from blood sample at baseline level (before intervention) and 48 hours after deresuscitation	2 days
Secondary	Central Venous Pressure	Central venous pressure measurement using central vein catheter every 6 hours during deresuscitation	2 days
Secondary	28 days mortality	mortality within 28 days admission to ICU: deceased or survived	28 days
Secondary	Total Body Water (TBW)	Total Body Water measured using Bioelectrical Impedance Analysis. The total body water consists of Extracellular Water (ECW) and Intracellular Water (ICW). Measurements are conducted at baseline (before intervention) and 48 hr after intervention.	2 days
Secondary	Extracellular Water (ECW)	Extracellular Water (ECW) using Bioelectrical Impedance Analysis. Measurements are conducted at baseline (before intervention) and 48 hr after intervention.	2 days
Secondary	Intracellular Water (ICW)	ICW measured using Bioelectrical Impedance Analysis. Measurements are conducted at baseline (before intervention) and 48 hr after intervention.	2 days